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Despite that the same enteric polymer, methacrylic acid ethyl acrylate copolymer (1 1), was applied to all commercial multiparticulate-based products, marked differences were observed between dissolution profiles of these preparations.
The similarity index value between dissolution profiles of optimized formulation before and after storage was found to be 86.82.
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Also significant variances between dissolution profiles for buccal tablets, using either USP Paddle or flow through cell methods were found.
No significant difference was observed between the dissolution profiles of orifice only on the side of the drug layer and orifices of the same diameter on both sides.
Besides the remarkable enhancement of drug dissolution rate of the granulates in comparison to physical mixtures and pure drug, no significant differences were found between the dissolution profiles of the granulates containing lactose or crospovidone.
The differences between the dissolution profiles of the thermally treated tablets with different excipients were not significant; 100% of the data was not statistically significant (P > 0.05).
The differences between the dissolution profiles of the tablets that contained 60% Avicel and those prepared by using 30% Avicel and 30% lactose were significant (P < 0.05).
A literature review revealed current gaps in the quality assurance of domestic generics in China; specifically, there are significant differences between the dissolution profiles of off-patent originators and domestic generics.
In summary, significant variations were observed between the dissolution profiles of 6 mesalamine formulations examined at a range of pH values, with a few formulations also exhibiting wide tablet-to-tablet variation in the release of 5-ASA.
However, it is still not known whether a correlation exists between the in vitro dissolution profiles of these formulations and their release characteristics in the colon.
Since the maximum plasma concentrations in vivo were reached between 40 and 60 min and the dissolution profiles of the IR tablets provided little information at later time points, all further dissolution tests with the remaining batches were decided to be run with the same fasted state method but terminated directly after the sampling point at 43 min.
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